Senior Product Complaints Analyst
Illumina · Manyata, India
The apply link worked recently (not employer-confirmed).
Role summary
This senior-level role involves managing product complaint investigations and quality activities for a genomics company. Responsibilities include assessing adverse events, leading process improvements, facilitating cross-functional investigations, and preparing regulatory documentation. The position requires 5–7 years of life-sciences experience with medical device or diagnostics background, knowledge of quality regulations, and strong project leadership skills.
What they're looking for
- Bachelor's degree in engineering or science discipline; advanced degree preferred
- 5-7 years life sciences industry experience; medical device or IVD background preferred
- Knowledge of regulatory standards: 21CFR820, ISO 13485, ISO 14971, IVDR
- Experience with complaint management and post-market sustaining activities
- Demonstrated ability leading cross-functional projects
- Proficiency with Microsoft Office and standard office tools
- Quality certification such as CQA or CQE a plus
What you'll be doing
- Identify, assess, and escalate potential adverse events and field actions to Regulatory
- Lead product and process improvements to reduce complaints and quality costs
- Facilitate complaint investigations including assessment, containment, and CAPA activities
- Develop and maintain complaint process documentation; train cross-functional teams
- Write and review quality documents including investigation reports and regulatory responses
Privacy & handoff
This role links to Illumina's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.